NCT06031233

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 776 (estimated)
• Sponsor: Isala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.

Detailed description

After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs. Patient satisfaction will be evaluated.

Conditions

• Oncology
• Infusion Reaction

Interventions

Type	Name	Description
DRUG	Nivolumab	Gradual shortening of infusion times
DRUG	Pembrolizumab	Gradual shortening of infusion times
DRUG	Ipilimumab	Gradual shortening of infusion times
DRUG	Durvalumab	Gradual shortening of infusion times
DRUG	Atezolizumab	Gradual shortening of infusion times
DRUG	Bevacizumab	Gradual shortening of infusion times
DRUG	Trastuzumab	Gradual shortening of infusion times
DRUG	Rituximab	Gradual shortening of infusion times

Timeline

• Start date: 2023-09-01
• Primary completion: 2028-07-01
• Completion: 2028-12-01
• First posted: 2023-09-11
• Last updated: 2026-03-30

Locations

1 site across 1 country: Netherlands